NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

Cordis

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231283

P04-6324

Details and patient eligibility

About

The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or non-pregnant female patients 18 years of age
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
3. Treatment of a single de novo target lesion in a major native coronary artery;
4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
5. Target lesion is 30mm in length (visual estimate);
6. Target lesion stenosis is > 50% and < 100% (visual estimate);

Exclusion criteria

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
3. Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Documented Left ventricular ejection fraction 25%;
5. Totally occluded vessel (TIMI 0 level);
6. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Description:

CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

Treatment:

Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)